Job Details

Stryker

http://www.stryker.com

Customer Quality Engineer

Occupation: Customer Service

Specialty: Customer Service

Visa sponsorship provided: No

Location: Redmond, Washington, United States

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is hiring a Customer Quality Engineer (Hybrid or Onsite) in Redmond, WA.

The candidate will need to live within a reasonable commuting distance to our Redmond, WA facility. You will need to be in the office a minimum of 3 days a week but will have the flexibility to work from home on the other days.

Who we want:

Analytical Problem Solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
User-focused Creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
Data Translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

What you will do:

Responsible for continuous product and process quality improvements. Conducts investigations into NCs and CAPAs stemming from the products in the field. Leads root cause activities and identifies potential failure modes and risks and resolves customer issues appropriately. Knows and applies the fundamental concepts, practices, and procedures of the general Quality and Regulatory environment, Post-Market, in particular.

Essential Duties & Responsibilities

Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to identify opportunities for quality improvements.
Champion and take ownership of activities that lead to improvement in Physio-Control Quality metric (Q).
Lead and/or support NC and CAPA process and NC and CAPA investigations.
Communicate with customers, members of the Field Service and Sales organizations to gather information necessary to carry out investigations.
Provide outstanding customer support with investigation updates to internal and external customers.
Work with multifunctional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive resolution for NCs and CAPAs.
May support Engineering Change Orders (ECO) and Process Change Orders (PCO).
Support and communicate with complaint handling function to ensure trending information is accurate and up to date.
Champion determination of “true” root cause by utilizing appropriate problem-solving tools.
Document accurately and thoroughly NC and CAPA investigations.
Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
Calculate Failure/Harm occurrence rankings based on field data as required.
Lead risk documentation updates based on field data.
Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality report, design reviews, risk analyses, and customer research.
Develop statistical rationale for testing, when required, to address post market issues.
Develop the rationale for validation sample size, duration, and number of locations.
Support quality assurance engineering responsibilities after launch with post market monitoring and voice of customer.
Contribute to maintaining the risk management portfolio for product life.
Provide Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to the organization Present Post Market trending data to the business.
Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
Support field action related activities i.e. investigations, HHEs, presentations etc.
Support internal and external audits (FDA, ISO, MDSAP etc.).
Perform other related duties as assigned.

What you will need:

Basic Qualifications

Bachelor’s Degree

Preferred Qualifications

Bachelor’s Degree in Engineering or related field.
0-2 years of related experience preferred.
Previous experience in post market medical device investigation.
Prior related experience in a regulated environment.
Working knowledge of failure investigation techniques and related tools: 8D, 6 Sigma, Root Cause Analysis.
Ability to conduct and document a technical investigation with prior experience investigating, troubleshooting and root causing.
Microsoft Office (Outlook, Excel, Word, etc.).
Excellent oral and written communication skills.
Ability to solve problems in a high-volume environment and ability to work in a multi-functional team environment.
Attention to detail and timely project management skills.
ISO 13485 and ISO 14971.
Industrial statistical techniques.
Development and implementation of design and process controls.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.